Podcasts

Industry group the Biosimilars Forum recently put forth 3 policy proposals that it says could save the US healthcare system billions of dollars. This week on the podcast, we’ve invited the forum to tell us more about its proposals and other policy issues related to biosimilars.

While pay-for-delay issues have been big news on Capitol Hill recently, some experts have questions about whether these kinds of settlements are really at the heart of delayed biosimilar competition, and they offer alternative ways to think about—and to fix—the problem. This week on the podcast, we’re speaking with 2 such experts, Imron Aly, JD, and Joel Wallace, JD. Both are partners at Schiff Hardin LLP and have extensive experience with Hatch-Waxman and biosimilars intellectual property issues.

This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.

Amid growing concern about the skyrocketing cost of insulin in the United States, the FDA held a public hearing this month about biosimilar insulins. This week on the podcast, we catch up with one of the experts who testified at the hearing: Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient. He shares his thoughts with us on biosimilar insulins, interchangeability, biosimilar suffixes, and what milestones lie ahead as the United States approaches its 2020 transition of insulins to regulation as biologics.

The cost of cancer care is on the rise worldwide, and biosimilars present one option for bringing down costs. However, those savings depend on adoption and use of biosimilars, and hesitancy to use these agents on the part of prescribers has been well documented in the literature. One newly published study reported on a survey conducted among European Society for Medical Oncology (ESMO) members and attendees of the 2017 ESMO Congress in Madrid, Spain, concerning biosimilars. This week, we’re speaking with the study’s lead author, Rosa Giuliani, MD.

It’s no secret that the biosimilars market in the United States has been off to a sluggish start. In fact, former FDA Commissioner Scott Gottlieb, MD, went so far as to call the market anemic. While many stakeholders have called for steps like more education or greater regulatory clarity, a new option has been raised in recent weeks, and that’s doing away with the US biosimilars market altogether.

Recent months have seen a variety of proposals to bring down the cost of prescription drugs, but will any of them have staying power? This week, senior editor Allison Inserro speaks with Robin Feldman, professor at the University of California, Hastings, College of the Law, and author of the new book Drugs, Money, and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices.

The recent weeks and months have seen a number of policy proposals from the Trump administration that impact community oncologists. On this week's podcast, Laura Joszt, associate editorial director of The Center for Biosimilars®, caught up with Ted Okon, MBA, executive director of the Community Oncology Alliance.

Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address the misinformation.

In January of last year, several hospital groups, representing approximately 450 US hospitals, revealed plans to form a nonprofit generic drug company in a bold move designed to address generic drug shortages and high prices affecting their hospitals.

Those who follow the biosimilars space closely are aware that, in the context of the US market, legal concerns regarding biosimilars can be just as regulatory ones in informing how drug makers do business. One recent case that impacts on upon the biosimilars market was recently heard before the before the United States Supreme Court, and the outcome of the case will potentially impact drug makers seek patent protection for various aspects of their products.

Recently, a new systematic review evaluating US and European provider awareness of biosimilars found a persistent lack of education on both sides of the Atlantic. This week, The Center for Biosimilars® is speaking with Sonia T. Oskouei, PharmD, one of the authors of the review, about the findings.

Last year was a banner year for biosimilars, both in the United States and abroad. In this episode of the podcast, Laura Joszt, associate editorial director of The American Journal of Managed Care®, the parent publication of The Center for Biosimilars®, interviews senior editor, Kelly Davio, about the key developments in biosimilars last year.

Welcome to Season 2 of Not So Different, a podcast from The Center for Biosimilars®.

Recently, Louis Tharp, the cofounder and executive director of the patient advocacy organization the Global Healthy Living Foundation, visited our studios in New Jersey to talk about how high drug costs impact patients with rheumatic diseases, and how biosimilars can be part of the solution. Our podcast this week features a portion of our discussion about biologics, biosimilars, and the patient’s viewpoint.

This week on “Not So Different,” our guest is Ali McBride, PharmD, MS, BCPS. McBride is pharmacist who serves as the Clinical Coordinator for Hematology and Oncology at The University of Arizona Cancer Center. He’s also the lead author of a recent study that showed that using biosimilar filgrastim can expand patients’ access to treatment with obinutuzumab.

This week on the podcast, we’re pleased to welcome our guest, Leigh Purvis, MPA. Purvis is the director of health services research at AARP’s public policy institute. Her work focuses on a variety of prescription drug and mental health-related issue, with an emphasis on prescription drug pricing, biologic drugs, and prescription drug coverage under Medicare.

Last time on the podcast, we spoke with a practicing rheumatologist about his experience with biosimilars so far, but one of the most exciting prospects on the biosimilars horizon is the market entry of 2 approved anticancer biosimilars: trastuzumab and bevacizumab. This week, we’re delving into the world of supportive care and anticancer biosimilars with an oncology expert, Robert M. Rifkin, MD, FACP.

Today, we’re talking about state-level legislation concerning the substitution of interchangeable biosimilars, and how 1 specific piece of biosimilars-focused legislation led Marcus Snow, MD, to found the Nebraska Rheumatology Society.

“If legislators want to be able to tell their constituents that they acted on drug prices this year, this is the vehicle to do it. There is nothing else with this kind of support and with this kind of impact sitting before legislators right now,” said Christine Simmon, JD, executive director of the Biosimilars Council, about the bipartisan CREATES Act.

“We need all stakeholders to be all in on biosimilars…now’s the time for people to get engaged and get out there to support uptake and access,” says our guest, Juliana Reed, president of Biosimilars Forum.

Our guest on this episode of "Not So Different" is Jim Van Lieshout, MBA, who joined us by phone from Colorado to discuss the many considerations that biosimilar developers must take into account when they determine how to price their products to compete in the marketplace.

In this episode of Not So Different, you’ll hear providers and patient advocates on the issue of nonmedical switching among brand-name biologics and biosimilars in rheumatology and oncology indications.

In this innaugural episode of "Not So Different," you’ll hear expert viewpoints on the issue of interchangeability from stakeholders across the biosimilars landscape.